News from GMP Area

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Response to ATMP GMP Guideline, 1th of September 2017

If you like to know what others think about the ATMP GMP guideline proposed by the European Commission (EC) and the European Medicines Agency (EMA), please read the summary of the EC:

“SUMMARY OF THE REPSONSES TO THE TARGETED STAKEHOLDER CONSULTATION ON THE DEVELOPMENT OF GOOD MANUFACTURING PRACTICE FOR ADVANCED THERAPY MEDICINAL PRODUCTS PURSUANT TO ARTICLE 5 OF REGULATION 1394/2007“.

All 53 comments received during the stakeholder consultation process from june to september 2016 were recorded, analyzed and summarized.

Most of the commentators welcomed the guideline. Requests remained on the relation between the actual draft guidelines on GMP specific to advanced therapy medicinal products to the GMP guidelines. They have to be clarified due to the specific characteristics of ATMPs. Therefore, some additional adaptations are required in terms of manufacturing conditions, validation of the aseptic manufacturing process, and ongoing stability testing. Just as important is a greater flexibility regarding the tasks of the qualified person.

Read the summary of the EC or have a look at the list of all comments submitted to the EC in detail.

 

Further information


 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".